This invention relates to the field of disease prevention, and more particularly to devices designed to prevent the spread of sexually transmitted diseases ("STD"'s).
The last decade has seen a remarkable rise both in the incidence of STD's and the impact of such diseases on the public consciousness. Penicillin and its progeny had relegated "traditional" STD's, such as gonorrhea, to a matter of little public concern by the end of the 1960's. That situation changed drastically, however, with the advent of herpes. A viral infection that proved resistant to all known forms of treatment, herpes presented a serious threat to persons who participated in frequent sexual activity with a number of partners. The public perception of the disease can be gauged from extensive media coverage, magazine articles and the like discussing the disease and its effect on sexual mores.
The impact of herpes, however, proved almost minuscule when the Acquired Immune Deficiency Syndrome (AIDS) epidemic surfaced in the 1980's. First identified only as a rare disease affecting homosexual men, the proportions of the problem exploded, with over 35,000 clinical AIDS cases currently, over 20,000 AIDS deaths, and with current estimates of up to 1.5 million infected Americans. Adding to the scope of the situation is the nature of the disease itself--simply put, no one has recovered from AIDS. The result has been an outpouring of concern, attention and research at all levels of society and government.
The nature of the disease contributes to the difficulty of preventing its spread. AIDS is caused by a virus, known as HIV, that attacks the human immune system-- the body's mechanism for fighting infections and other diseases. By reducing (or, finally, eliminating) the body's ability to combat bacterial or viral invaders, AIDS does not kill directly, but results in a series of ever more debilitating infections or diseases that finally lead to the patient's death.
Transmission of the AIDS virus from an infected person appears to be most closely associated with a sharing of bodily fluids, most notably semen and blood. The transmission role of other body fluids, such as saliva, tears, vaginal lubricants, etc., cannot be clearly identified at this time, but it must be said that the AIDS virus has been cultured form all of these fluids. Research to date indicates that the most common modes of transmission are activities that allow either the semen or blood of an infected person to make contact with the bloodstream of another.
Thus, the activities primarily linked with AIDS transmission are many forms of sexual intercourse and the sharing of apparatus used in intravenous drug injection. The latter, for example, clearly exemplifies the bloodstream-to-bloodstream pathway for viral migration. In the sexual activities mentioned, the opportunity arises for transmission owing to the frequent presence of small lacerations or lesions in either the oral, vaginal or rectal mucosa, thereby allowing the virus to gain access to the bloodstream. Anal intercourse is an especially dangerous activity in this regard, inasmuch as the activity itself does produce breaks in the skin or mucal tissue. The disease is expected to mushroom among the heterosexual population in the not too distant future.
The discussion above focuses on transmission of virus at the precise site of the sexual activity, as does the bulk of public discussion. Brief consideration, however, demonstrates that such a narrow focus could underestimate the risks of infection, leading to inadequate preventive measures. Given the proclivity of the virus to exploit any break in the skin, the entire perineum should be considered a danger zone. This area is anatomically defined as the diamond-shaped portion of the body lying between the thighs and delimited at the posterior by the coccyx (tailbone), anteriorly by the symphysis pubis (the pubic bone) and laterally by the two ischial tuberosities. As is well known, this area is highly prone to rashes, pimples, and skin infections, all of which produce breaks in the skin surface. Given the likelihood of semen making contact with the perineal area in a variety of sexual circumstances, a high risk exists of infection through such skin breaks.
Overwhelmingly, suggestions aimed at limiting the spread of AIDS have concentrated on changing sexual behaviors seen as likely to transmit the virus (the so-called "safe sex" movement), and the use of condoms during sex. The former effort has achieved some success, but approaches aimed at fundamental changes in human nature historically have fallen short of widespread acceptance. Such measures had limited effect on the spread, successively, of gonorrhea, syphilis, and herpes, and it can be presumed that similar results will be observed for AIDS.
Failing a massive change in behavior patterns, many see the condom as the only real solution to the containment of AIDS. Several serious drawbacks to that solution, however, limit the success of this method of prevention. First, a particular condom may not fulfill its function, either because it does not remain in position, or it breaks during use, or it may remain in position but serve as a conduit for infectious biological products to travel onto the perineum. This problem is particularly acute in anogenital intercourse, due to the general lack of clearance between the orifice and the penis. The danger of relying upon the condom in such situations is exacerbated, of course, by the fact that this activity perhaps poses the greatest danger of infection.
More seriously, however, are the condom's inherent drawbacks. As mentioned above, the perineum offers a number of sites for viral entry to the bloodstream, yet the condom offers no protection whatsoever in this area. Moreover, spillage of semen from a condom is a common occurrence, and leakage is practically guaranteed, especialy when the wearer is supine. The condom is neither designed nor commonly used for the purpose of preventing contact between semen and the perineum of either or both partners, and thus it is not surprising that it does not serve that purpose. The risk presented by such contact, however, makes the condom a limited tool for preventing the spread of AIDS.
Additionally, the fact that the condom wearer or the partner must manually handle the condom after it has been used presents a high risk situation. Even if the used condom is handled carefully, avoiding spillage onto the perineal area (by no means an easy task), the occurrence of cuts, lacerations or lesions on the fingers or hands is common, and contact between such a skin break and semen from an infected person offers a ready path for entry of AIDS virus into the bloodstream.
The art has thus far failed to offer any solution having significantly more preventive utility than does the condom. In U.S. Pat. No., 3,759,254, Clark discloses a "Hygienic Appliances," consisting of a tubular condom-like member integral with a sack for covering the scrotum. Although this device does shroud the scrotum, it suffers from the inherent deficiencies of the condom, in that it allows for the free escape of semen and subsequent contact with skin breaks in the perineum.
A more comprehensive approach is seen in U.S. Pat. No. 3,536,066, entitled "Human Birth Control Appliances", issued to Ludwig. This device can essentially be described as a bikini-like garment incorporating in the front portion a reversible proboscis. The proboscis portion is formed with accordion-like bellows folds to allow for extension, and thus the area overlying the genitals initially is somewhat flat. From that position, the device can be worn by a man or woman, the proboscis extending respectively outward or inward to provide a physical barrier between the genitalia.
The limiations of this device inhere in its stated teaching that it is designed to prevent impregnation and additionally to prevent the transmission of venereal disease. It should be noted that the issuance of this patent, in 1970, antedates the problem of herpes by a number of years, and precedes the AIDS epidemic by over a decade. Thus, no thought is given to the risk of semen making contact with the perineum of either partner, a situation that the bikini design makes inevitable. Furthermore, the bellows fold design is particularly undesirable for use in anogenital intercourse, as the folds will make penetration more difficult than normal, and this sizing problem probably would altogether rule out the use of the device by both partners, which of course is the situation of maximum desirability. And not only would the device prove impossible or difficult to use in such situations, but it could aggravate the situation by causing more tissue damage than is normally associated with anogenital activity, thus increasing the chances of infection at that or a later time.
Thus it is seen that the art has failed to produce a device that affords a complete barrier between all areas susceptible to the introduction of AIDS, herpes virus, or other STD's into the bloodstream. It is that need that the present invention meets fully and conveniently.